Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.
See brief summary above
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday
UNC at Chapel Hill
Chapel Hill, North Carolina, United States
Change in Mean Arterial Blood Pressure (MAP)
Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP through 24 hours after study drug administration.
Time frame: Baseline, 48 hours
Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)
Time frame: Within 24 hours of any dose, up to a maximum 4 weeks
Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)
Time frame: Within 24 hours of any dose, up to a maximum 4 weeks
Number of Participants With Maternal Side Effects
Maternal side effects are defined as: facial erythema, hives, sore mouth, dry hair, fatigue, flushing, headache, nausea, and heart burn.
Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Women Maternal Abdominal Tenderness
Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Women With Headache Unrelieved by Oral Analgesics
Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Women With Hematocrit Decrease of More Than 3%
Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
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Percentage of Women With Less Than 500 cc Urine Output in 24 Hours
Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Fetuses With Category III Non Stress Test Results
A Non Stress Test is a determination of the current well-being of the fetus, as measured by the fetal heart rate. Category I indicates that the fetus is in a state of well-being and is tolerating the intrauterine environment. Category II indicates a fetal heart rate that is showing some signs of distress. In this instance, obstetric providers will try to improve the intrauterine environment to allow the pregnancy to continue. Category III relates to a fetus whose well-being is compromised - usually requiring rapid intervention, ie expedient delivery.
Time frame: From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks
Percentage of Fetuses With Biophysical Profile < 6
Time frame: From initial administration of study agent until 24 hours post last dose
Mean Peak Nicotinamide Level
The mean was calculated for each group using blood samples drawn on Day 1 at 1 hour post 1000 mg nicotinamide administration routinely given at 8 a.m. Peak nicotinamide level expected at 1 hour post dose.
Time frame: at 1 hour post 1000 mg nicotinamide administration on Day 1
Mean Trough Concentration Nicotinamide Administration
The mean was calculated for each group for blood samples drawn on Day 1 8 hours post 1000 mg nicotinamide administration routinely given at 8 a.m. Trough nicotinamide level is measured immediately prior to the next dose.
Time frame: 8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1